机构:[1]Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China广东省中医院[2]Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China大德路总院皮肤科大德路总院皮肤科广东省中医院[3]Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome, Guangzhou 510120, China[4]Department of Public Health Sciences (Global Health/IHCAR), Karolinska Institutet, 17177 Stockholm, Sweden[5]Department of Otorhinolaryngology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China大德路总院珠海院区耳鼻喉科耳鼻喉科广东省中医院[6]Department of Acupuncture and Moxibustion, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China大德路总院针灸科大德路总院针灸科广东省中医院[7]Department of Nephropathy, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China大德路总院肾内科大德路总院肾内科广东省中医院[8]National Centre for Design Measurement and Evaluation in Clinical Research, Guangzhou University of Chinese Medicine, Guangzhou 510405, China深圳市中医院深圳医学信息中心
Background. The Sanfu herbal patch (SHP) has been widely used to treat allergic rhinitis (AR) in China. SHP has been reported to be effective for managing the symptoms of AR, but the evidence suffers from methodological limitations. Therefore, we designed a three-armed, randomized, and placebo-controlled trial to evaluate the efficacy and safety of SHP for persistent allergic rhinitis (PAR). Methods. The trial consists of 5 treatment sessions along with a one-year follow-up. This process is then repeated in the second and third years. Eligible participants diagnosed with PAR were randomized at a ratio of 2 : 2 : 1 into one of three groups: (a) SHP group; (b) placebo group; or (c) waiting-list group. The waiting-list group will receive no treatment in the first year but will receive SHP in the following two years. The primary outcome, total nasal symptoms score, is self-assessed at the beginning of each treatment session and during each annual follow-up. Secondary outcomes include the Rhinoconjunctivitis Quality-of-Life Questionnaire, allergic rhinitis attacks, and relief medications. The trial will be stopped if early termination criteria are met during the interim analysis.
基金:
Guangdong
Provincial Hospital of Chinese Medicine (no. 2014YNE431)
and the Traditional ChineseMedicine Bureau of Guangdong
Province (no. 20151201).
第一作者机构:[1]Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China
通讯作者:
通讯机构:[1]Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China[8]National Centre for Design Measurement and Evaluation in Clinical Research, Guangzhou University of Chinese Medicine, Guangzhou 510405, China
推荐引用方式(GB/T 7714):
Chen Xiankun,Lu Chuanjian,Stalsby-Lundborg Cecilia,et al.Efficacy and Safety of Sanfu Herbal Patch at Acupoints for Persistent Allergic Rhinitis: Study Protocol for a Randomized Controlled Trial[J].EVIDENCE-BASED COMPLEMENTARY AND ALTERNATIVE MEDICINE.2015,2015:doi:10.1155/2015/214846.
APA:
Chen, Xiankun,Lu, Chuanjian,Stalsby-Lundborg, Cecilia,Li, Yunying,Li, Xiaoyan...&Wen, Zehuai.(2015).Efficacy and Safety of Sanfu Herbal Patch at Acupoints for Persistent Allergic Rhinitis: Study Protocol for a Randomized Controlled Trial.EVIDENCE-BASED COMPLEMENTARY AND ALTERNATIVE MEDICINE,2015,
MLA:
Chen, Xiankun,et al."Efficacy and Safety of Sanfu Herbal Patch at Acupoints for Persistent Allergic Rhinitis: Study Protocol for a Randomized Controlled Trial".EVIDENCE-BASED COMPLEMENTARY AND ALTERNATIVE MEDICINE 2015.(2015)